Compact packaged intermittent urinary catheter

ABSTRACT

A compact packaged intermittent urinary catheter having a longitudinally elongated intermittent urinary catheter retained within a longitudinally compacted elastic package. A method of using the catheter wherein at least a portion of the package is used as a drainage tube for the catheter. A package for an intermittent urinary catheter including a longitudinally compacted elastic package having a longitudinally extending receiving chamber containing a lubricating medium. The package having two longitudinal ends that may be removed to open the package and enable conversion of the package from a compacted state to an extended state. A method of using the package as a clean handling sleeve through which an intermittent urinary catheter may be passed to coat it with a lubricating medium.

RELATED APPLICATION INFORMATION

This patent is a continuation-in-part of application Ser. No. 15/707,817filed Sep. 18, 2017 and now issued as U.S. Pat. No. 10,265,500, which isa continuation of application Ser. No. 15/094,749 filed Apr. 8, 2016 andnow issued as U.S. Pat. No. 9,764,112, which is a continuation-in-partof application Ser. No. 13/790,495 filed Mar. 8, 2013 and now issued asU.S. Pat. No. 9,694,157, all titled “COMPACT PACKAGED INTERMITTENTURINARY CATHETER.”

NOTICE OF COPYRIGHTS AND TRADE DRESS

A portion of the disclosure of this patent document contains materialwhich is subject to copyright protection. This patent document may showand/or describe matter which is or may become trade dress of the owner.The copyright and trade dress owner has no objection to the facsimilereproduction by anyone of the patent disclosure as it appears in thePatent and Trademark Office patent files or records, but otherwisereserves all copyright and trade dress rights whatsoever.

BACKGROUND

Intermittent catheters are typically used by patients suffering fromurinary incontinence or by individuals unable to have voluntaryurination. In our highly mobile culture, the ability to have the freedomto leave home for the day or longer is an important part of life. Toaccommodate this need single use catheters have been developed to allowpatients to perform self catheterization. These catheters and theirdrainage tubes typically have a considerable length and are packaged inan elongated condition. It can require a considerable amount of space tostore and transport enough catheters to accommodate a day long outing.

U.S. Pat. No. 7,682,353 B2 discloses an intermittent catheter kit thatprovides a catheter in short sections to be assembled at the time ofuse, but many users of the catheters have limited dexterity to assemblethese catheters and may still need drainage tubes to reach a wastereceptacle. A need still exists for an easy to use intermittent catheterthat is compact and completely assembled upon opening the package.

SUMMARY OF THE INVENTION

A first aspect of the invention is a compact packaged intermittenturinary catheter. The catheter has a longitudinally elongatedintermittent urinary catheter retained within a longitudinally compactedelastic package.

In a preferred embodiment the compacted package is folded or coiled suchthat removal of one end of the package removes the other end of thepackage.

A second aspect of the invention is a method of using a catheter inaccordance with the first aspect of the invention. The method includesthe steps of (a) obtaining a compact packaged intermittent urinarycatheter retained within a longitudinally compacted elastic packagehaving a first longitudinal end and a second longitudinal end, (b)manually opening the first and second longitudinal ends of the package,(c) returning the package to a full longitudinal length, (d) removing aportion of the catheter from the package and inserting it into aurethra, and (e) using at least a portion of the package as a drainagetube for the catheter.

A further aspect comprises a compact package for an intermittent urinarycatheter. The package is longitudinally compacted and elastic and has anopen extended state and a closed compacted state. The package furtherdefines a longitudinally extending receiving chamber containing alubricating medium. The package is sized and configured when in itscompacted state such that a first longitudinal end of the package and asecond longitudinal end of the package are aligned and attached togetherand removal of the first longitudinal end causes removal of the secondlongitudinal end and opening of the package. Also, removal of both firstand second longitudinal ends permits the package to be converted to itsextended state with both first and second longitudinal ends being open.The longitudinally extending receiving chamber is sized and configuredwhen the package is in its open extended state to slidably receive alongitudinally elongated intermittent urinary catheter so that thelubricating medium coats the catheter exterior.

The compact package may be made from polyester, polyethylene, or acombination of the two materials. A line of weakness proximate the firstlongitudinal end of the package and the second longitudinal end of thepackage may be provided wherein the lines of weakness are aligned whenthe first longitudinal end of the package and the second longitudinalend of the package are aligned and attached together. Preferably, thecompacted state of the package includes a single fold with the first andsecond longitudinal ends being joined together opposite the fold.Alternatively, the compacted state of the package includes a coiledconfiguration. The compact package may have a hinge to allow the packageto be configured and arranged into its compacted state.

Additionally, the compact package may have at least one set of laterallyextending dimples configured and arranged to allow the package to befolded into its compacted state. The compact package may also have abiasing means configured and arranged to bias the package toward itsextended state, such as a polymer member or at least one pressurizedchamber.

A method of using an intermittent urinary catheter is also describedincluding the steps of:

-   -   a. obtaining, in its closed compacted state, the package for an        intermittent urinary catheter as set forth in claim 1;    -   b. simultaneously removing the first and second longitudinal        ends of the package so that both first and second longitudinal        ends are open;    -   c. converting the package to its extended state;    -   d. inserting a leading end of an intermittent urinary catheter        into the open first longitudinal end and passing the catheter        through the longitudinally extending receiving chamber so that        the leading end projects from the open second longitudinal end        with lubricating medium coating an exterior surface thereof;    -   e. inserting the catheter leading end into a urethra; and    -   f. using at least a portion of the package as a clean handling        sleeve for the catheter.

The package preferably includes a single fold with the first and secondlongitudinal ends being joined together opposite the fold, and the stepof converting the package to its extended state comprises unfolding thepackage.

BRIEF DESCRIPTION OF THE DRAWINGS

FIG. 1 is a front plan view of one embodiment of a package for anintermittent urinary catheter shown with the package in fulllongitudinal length.

FIG. 2 is a front plan view of the package in FIG. 1 shown with thepackage in compact longitudinal length.

FIG. 3 is a side plan view of the package in FIG. 2

FIG. 4 is a cross-sectional side view of the package shown in FIG. 2taken along line 2-2.

FIG. 5 is a side plan view of the package shown in FIG. 1 with the firstand second longitudinal ends removed.

FIG. 6 is a cross-sectional front view of the package shown in FIG. 5taken along line 5 a-5 a with the catheter fully extended.

FIG. 7A is a plan end view of the second longitudinal end of the packageshown in FIG. 5.

FIG. 7B is a plan end view of an alternative configuration of the secondlongitudinal end of the package shown in FIG. 5.

FIG. 7C is a plan end view of a further alternative configuration of thesecond longitudinal end of the package shown in FIG. 5.

FIG. 8 is a side perspective view of a second embodiment of the packagewith the first and second longitudinal ends removed and the catheterpartially extended.

FIG. 9 is a plan side view of a third embodiment of the invention withthe package shown in compact longitudinal length.

FIG. 10 is a plan front view of a fourth embodiment of the package shownin full longitudinal length.

FIG. 11A is a side perspective view of proximal end of the cathetershown In FIG. 6.

FIG. 11B is a side perspective view of an alternative configuration ofthe proximal end of the catheter shown in FIG. 6.

FIG. 11C is a side perspective view of a further alternativeconfiguration of the proximal end of the catheter shown in FIG. 6.

FIG. 11D is a side perspective view of a further alternativeconfiguration of the proximal end of the catheter shown in FIG. 6.

FIG. 11E is a front perspective view of the proximal end of the cathetershown in

FIG. 11D.

FIG. 12 is a sectional front view of the invention in FIG. 1 with airpockets molded into the package to act as a biasing means.

FIG. 13 is a sectional front view of the invention in FIG. 1 with aspring sealed into the package to act as a biasing means.

FIG. 14 is a front perspective view of an alternative form of a packageto receive and lubricate an intermittent urinary catheter in compactlongitudinal length.

FIG. 14A is a cross-sectional side view of the package shown in FIG. 14taken along line 14-14.

FIG. 15 is a perspective view of the package shown in FIG. 14 with thefirst and second longitudinal ends removed by a user and in a compactlongitudinal length.

FIG. 16 is a perspective view of the package of FIG. 14 after removal ofthe first and second longitudinal ends and in full longitudinal length.

FIG. 17 is a perspective view of the package of FIG. 14 after removal ofthe first and second longitudinal ends and in full longitudinal lengthshowing a user inserting an intermittent urinary catheter therein.

FIG. 18 is a perspective view like FIG. 17 showing the intermittenturinary catheter passing completely through the package.

FIG. 19 is a perspective view like FIG. 18 showing the user holding thepackage with the intermittent urinary catheter therein in preparationfor use.

FIGS. 20A and 20B are longitudinal sectional and side views of analternative intermittent urinary catheter package in a foldedconfiguration, and FIG. 21 shows the package unfolded with open ends.

FIG. 22A is a longitudinal sectional view of another intermittenturinary catheter package in a folded configuration, and FIG. 22B showsthe package unfolded with opposite open ends.

FIG. 23 is a side view of a funnel having a biasing tongue which forms arear end of a catheter in the package of FIG. 22A.

FIG. 24A is a side view of a still further intermittent urinary catheterpackage in a folded configuration, and FIG. 24B shows the packageunfolded and a catheter extended from one open end.

FIG. 25 shows a convenient method for disposing of the package of FIG.24A.

FIG. 26A is a side view of another intermittent urinary catheter packagein a folded configuration, and FIG. 26B shows the package unfolded and acatheter being expelled from one open end thereof.

DETAILED DESCRIPTION OF A PREFERRED EMBODIMENT

Nomenclature: 10 Catheter; 11 Distal end; 12 Proximal end; 12 a Pushblock; 13 Longitudinal length; 14 Eyelet; 20 Package; 21 Fulllongitudinal length; 22 Compact longitudinal length; 23 Firstlongitudinal end; 24 Second longitudinal end; 25 Hinge [0038; 26 a Innersurface; 26 b Outer surface; 27 Edge; 28 Receiving chamber; 28 aLongitudinal length; 28 b Shoulder; 29 Line of weakness; 30 Guidemember; 31 Tab; 32 Tether; 40 Mirror; 50 Fastener; 60 Dimple; 70 Biasingmeans; X Longitudinal direction; Y Lateral direction.

Definitions

As utilized herein, including the claims, the phrase “full longitudinallength” means longitudinal length from the first end of the package tothe second end of the non-compacted package.

As utilized herein, including the claims, the phrase “compactlongitudinal length” means longitudinal length of the compacted packagethat is less than the full longitudinal length.

As utilized herein, including the claims, the term “compacted” meansfolded, coiled, pleated, concertina, bent.

As utilized herein, including the claims, the term “elastic” means ableto resume to proximate normal shape spontaneously after bending,coiling, pleating, or other form of distortion.

Description

Construction

The invention is a longitudinally elongated intermittent urinarycatheter 10 packaged in a longitudinally compacted elastic package 20and a method of using the catheter 10.

FIG. 1 shows an embodiment of the catheter 10 sterilely packed inside apackage 20. The package 20 is shown in full longitudinal length 21. Thecatheter 10 has at least a distal end 11, a proximal end 12, alongitudinal length 13, a lumen (not numbered), and at least one eyelet14 (FIG. 6). The distal end 11 is preferably round ended to allow easyand pain free insertion into the urethra of a patient. The distal end 11has one or more eyelets 14 to accommodate flow of the urine from thebladder through the lumen of the catheter 10. Preferably the eyelets 14are provided with rounded and or polished rims (not numbered) toincrease comfort to the patient during insertion. The proximal end 12 ofthe catheter 10 provides an exit for the urine from the lumen.

The diameter of the proximal end 12 of the catheter 10 is preferablylarger than the diameter of the distal end 11. The proximal end 12 maybe any suitable shape to accommodate sliding along the full longitudinallength 21 of the package 20 without exiting the package 20.

The catheter 10 may be coated with a hydrophilic coating to provide alow friction surface when treated with a swelling medium. A swellingmedium may be provided within the package 20 to provide a ready to usecatheter 10. The use of hydrophilic coating and prepackaged swellingmediums with catheters 10 is well known in the industry. A lubricant mayalso be provided in the package 20 to provide a low friction surface.Providing a lubricant in a catheter 10 package 20 is well known in theindustry.

The catheter 10 may have any desired longitudinal length 13 and shapeeffective for achieving the function of eliminating urine from thebladder of a male or female patient, including the hollow cylinder ortube shape as shown in FIGS. 1, 4, and 6. Preferably, the longitudinallength 13 for an adult female catheter 10 is between 2-6 inches, thelongitudinal length 13 of the adult male catheter 10 is between 10-16inches, and the longitudinal length 13 of a pediatric catheter 10 isbetween 5-11 inches.

The catheter 10 may be constructed from any material possessingsufficient structural integrity, being light weight, and having a smoothfinish, including specifically, but not exclusively, plastics such aspolyethylene, polyvinyl chloride and polyurethane, etc. The catheter 10may be made without a softening agent also or with a softening agentallowing the catheter 10 to be pliable. Pliability is especially desiredfor the longer male catheter 10 to allow the catheter 10 to be stiffenough for insertion but to allow enough flexibility to manipulatethrough the longer urethra of the male anatomy. The catheter 10 may alsobe elastic like the package 20. Using an elastic catheter 10 would allowthe catheter to be compacted to fit into a smaller package 20. Anelastic and pliable catheter 10 may decrease the chances of the catheter10 forming kinks if it is compacted in the package. An elastic catheter10 may also aid the package 20 in resuming the full longitudinal length21 upon opening of the package 20.

Preferably the catheter 10 is packaged in an elastic package 20. Asshown in FIGS. 2-4 and 9, the package 20 is stored in a compact statedefining a compact longitudinal length 22. The package 20 has a compactlongitudinal length 22 that is less than the full longitudinal length21. The elasticity of the package 20 may come from elastic material usedto form the package 20 or from a biasing means 70 incorporated into thepackage 20 wherein the package 20 is biased toward the full longitudinallength 21.

If an elastic material is used to form the package 20, the elasticity ofthe packaging material biases the package 20 to the full longitudinallength 21. Preferably the package 20 is made from polyester,polyethylene, or a combination of the two materials, Surlyn,polyprolene, or aluminum. Additional package materials includethermoplastic elastomer (TPE), or a polyurethane material or acombination of those materials with other disclosed materials. Thepackage could be either formed from films or possibly extruded into atubular shape. Once the catheter is packaged a vacuum could be used todraw the package onto the catheter and once the package is opened andthe vacuum released the package would rebound to original shape.

At least one biasing means 70 may also be used to provide the elasticityof the package 20. Any acceptable biasing means 70 may be used, such asbut not exclusively, a spring. As shown in FIGS. 12 and 13, the biasingmeans 70, is sealed into or molded as part of the package 20. Thepreferred biasing means 70 is a polymer member or a pressurized chamber.The chamber may be filled with any suitable pressurized fluid such aswater or a gas. To increase the elasticity of the package 20 more thanone biasing means 70 may be used in a single package 20.

Preferably the inner surface 26 a of the package 20 material is smoothto allow for ease in removing the catheter 10 for use and to preventdamage to the catheter 10. FIG. 1 shows the package 20 in a fulllongitudinal length 21. FIGS. 2-4 and 9 show the package 20 in itscompact state where the compact longitudinal length 22 is less than thefull longitudinal length 21.

The package 20 has a first longitudinal end 23 and a second longitudinalend 24 and defines an elongate catheter 10 receiving chamber 28extending along a portion of the full longitudinal length 21 of thepackage 20. The catheter 10 is carried in the elongate receiving chamber28 with the distal end 11 of the catheter 10 located proximate the firstlongitudinal end 23 of the package 20. As shown in FIG. 1, a firstembodiment of the package 20 may be constructed from a base sheet ofmaterial and cover sheet of material sealed along the edges 27 to formthe catheter 10 receiving chamber 28 therein. See FIG. 7A. The firstlongitudinal end 23 and the second longitudinal end 24 are sealed afterinsertion of the catheter 10 in the receiving chamber 28. A secondembodiment of the package 20 may also be constructed from a single basematerial folded upon it to provide a single sealed edge 27. See FIG. 7C.The first longitudinal end 23 and second longitudinal end 24 are thensealed after insertion of the catheter 10 in the receiving chamber 28.In a third embodiment, the package 20 may be extruded in a tube shapeand then the first longitudinal end 23 and second longitudinal end 24sealed after insertion of the catheter 10 in the receiving chamber 28.As shown in FIG. 7B, the extruded shape may include longitudinal Xcreases to allow for flexibility of the package 20 during use.

As shown in FIGS. 1 and 6, the catheter 10 receiving chamber 28 extendsfrom proximate the first longitudinal end 23 of the package 20 toproximate the second longitudinal end 24 of the package 20, as the firstlongitudinal end 23 and the second longitudinal end 24 are sealed afterthe catheter 10 is inserted in the receiving chamber 28. The receivingchamber 28 is sized, configured, and arranged to slideably engage thecatheter 10. Preferably, proximate the first longitudinal end 23 of thepackage 20 the size of the receiving chamber 28 is an inwardly directedshoulder 28 b effective for decreasing the size of and constricting thereceiving chamber 28 such that the shoulder 28 b is sized, configured,and arranged to prohibit movement of the proximal end 12 of the catheter10 from exiting the receiving chamber 28 of the package 20.

Preferably, the package 20 has means to manually remove the firstlongitudinal end 23 and the second longitudinal end 24 to allow accessto the catheter 10 receiving chamber 28. The ends 23 and 24 may have aline of weakness 29 such as perforations or score lines, a tear strip,or a point of weakness to allow easy opening of the package 20 withoutthe need for scissors or a knife. Providing a line of weakness 29 mayalso direct the patient to open the package 20 at the proper place onthe package 20 to allow the proximal end 12 of the catheter 10 to catchon the shoulder 28 b of the receiving chamber 28.

As shown in FIGS. 2-4 and 9, the package 20 has a compact longitudinallength 22 that is shorter than the full longitudinal length 21 of thepackage 20. Preferably the longitudinal length 13 of the catheter 10 isless than the longitudinal length 28 a of the receiving chamber 28. If anon-elastic catheter 10 is used this will allow the portion of thepackage 20 without the catheter 10 to be folded, bent or coiled to formthe compacted package 20. It will also provide a longer receivingchamber 28 for use as a drainage tube during use of the catheter 10.

In the compact longitudinal length 22 the first longitudinal end 23 andthe second longitudinal end 24 may be configured and arranged to beremoved from the package 20 at the same time by aligning the removalmeans for each end as shown in FIGS. 3-4 and 9. Preferably thelongitudinal ends 23 and 24 are aligned and a fastener 50 used to attachthe first end 23 to the second end 24 such that the patient cannotremove the first longitudinal end 23 without removing the secondlongitudinal end 24. The preferred fastener 50 is an adhesive.

The package 20 may be converted from the full longitudinal length 21 tothe compacted length 22 by folding, coiling, bending, or pleating. Asshown in FIGS. 2-4 and 10 the package 20 may be folded or bent a singletime. The folding may be made easier by using a hinge 25, score line, orat least one set of laterally Y extending dimples 60 at the point offolding. The hinge 25 may be a live hinge 25 or a mechanical hinge 25.As shown in FIG. 8, the package 20 may be folded or bent more than onetime to accommodate a package 20 with a longer full longitudinal length21. This could allow for a longer drainage tube as well as toaccommodate a longer catheter 10. As shown in FIG. 9, the package 20 maybe coiled into the compact length 22. Again the package 20 may have oneor more coils depending on the original full longitudinal length 21 ofthe package 20. As the package 20 is elastic, a fastener 50 may beneeded to attach the first longitudinal end 23 of the package 20 to thesecond longitudinal end 24 to keep the package 20 in the compactposition. Upon removing the longitudinal ends 23 and 24 of the package20 or removing the fastener 50 from contact with one of the ends 23 and24 of the package 20, the package 20 will return to the fulllongitudinal length 21.

As shown in FIG. 2 the package 20 may also have a mirror 40 on the outersurface 26 b to aid the patient in inserting the catheter 10. Thepackage 20 may have a minor like outer surface 26 b to aid the patientin inserting the catheter 10.

The package 20 may also have a guide member 30 to aid the patient inremoving the distal end 11 of the catheter 10 from the package 20without touching the catheter 10 and causing contamination. Preferablythe guide member 30 has a tab 31 and a tether 32. As shown in FIG. 1,the tab 31, with one end (not numbered) of the tether 32, is attached tothe first longitudinal end 23 of the package 20 and the other end (notnumbered) of the tether 32 is attached to the distal end 11 of thecatheter 10. As shown in FIGS. 1 and 6, the tab 31 may be embedded inthe seal of the first longitudinal end 23 of the package 20 whereinremoval of the first longitudinal end 23 from the package 20 removes thetab 31 allowing the distal end 11 of the catheter 10 to be pulled out ofthe package 20 with the tab 31.

Alternatively, the proximal end 12 of the catheter 10 may be configuredand arranged to allow the distal end 11 of the catheter 10 to bemanually pushed out of the open longitudinal end of the package 20. Asshown in FIGS. 1 and 11A-E, the proximal end 12 of the catheter 10 maybe attached to or integrally formed with a push block 12 a. The pushblock 12 a is shaped to allow a patient to easily grip the proximal end12 of the catheter 10 through the package 20 and push the distal end 11of the catheter 10 out of the opened first longitudinal end 23 of thepackage 20.

Use

The compact packaged intermittent urinary catheter 10 is used bypatients for self-catheterization. One or more of the compact packagedcatheters 10 may be easily carried by a patient in a purse, bag orpocket. Prior to use the patient should take all sanitary proceduresadvised by their doctors to decrease the risks of infection fromutilizing a catheter 10. The patient grasps the first and secondlongitudinal ends 23 and 24 of the compact elastic package 20 andremoves the ends 23 and 24. The ends 23 and 24 may be removed by cuttingwith a knife or scissors, but preferably the ends 23 and 24 are removedmanually along the lines of weakness 29 or at the point of weakness. Asshown in FIGS. 5, 6, and 8, by removing the first longitudinal end 23and the second longitudinal end 24 at the point of weakness or line ofweakness 29, the package 20 will be open such that the receiving chamber28 are now open. Removing the first longitudinal end 23 of the package20 too far below the line of weakness 29 or the point of weakness couldcause the package 20 to be opened such that the shoulder 28 b of thereceiving chamber 28 is also removed and proximal end 12 the catheter 10will no longer be captured within the package 20.

Upon removal of the first and second longitudinal ends 23 and 24 of thepackage 20, the package 20 is then returned to its full longitudinallength 21.

If the package 20 has a guide member 30, removal of the firstlongitudinal end 23 of the package 20 will allow the distal end 11 ofthe catheter 10 to slide from the package 20 without the need to touchor contaminate the catheter 10. If the proximal end 12 of the catheter10 remains in the receiving chamber 28 of the package 20, the package 20can be used as a drainage tube for the catheter 10. The catheter 10 isthen inserted into the urethra of the patient. As the urine travelsthrough the catheter 10 and exits the proximal end 12 of the catheter10, it enters the receiving chamber 28 of the package 20 and travelsthrough the longitudinal length 28 a of the chamber 28 and out the nowopen second longitudinal end 24 of the package 20 and into a wastereceptacle.

If the catheter 10 has a push block 12 a proximate the proximal end 12of the catheter 10, after the package 20 is opened and the package 20returns to the full longitudinal length 21, the patient grasps the pushblock 12 a at the proximal end 12 of the catheter 10 through the package20 and pushes the distal end 11 of the catheter 10 out of the package 20without touching or contaminating the catheter 10. The catheter 10 maythen be used the same as the catheter 10 with the guide member 30.

After the bladder is emptied, the catheter 10 is removed from theurethra and the catheter 10 can be pushed back into the package 20 foreasy and mess free disposal.

The compact package described herein may be used to store a sterilecatheter packed therein or may be provided along with or separately fromthe catheter. In either case, the package is preferably used as an aidfor inserting the catheter into the urethra. The embodiments describedabove include the catheter stored in the package which also containslubricant to assist urethral insertion, or the catheter may beseparately inserted into the lubricant-filled package at the time ofusage. It should be noted that all of the variations described abovepertaining to the way the package is held in a compact shape, or whichassist in opening the package to its elongated shape apply equally tothe separate package described below Likewise, other constructionalaspects such as materials and dimensions described above may applyequally to the stand-alone package described below.

FIG. 14 is a front perspective view of an alternative form of a package80 for assisting insertion of an intermittent urinary catheter shown incompact longitudinal length, while FIG. 14A is a cross-sectional sideview of the package 80 taken along line 14-14.

The package 80 has a first longitudinal end 82 and a second longitudinalend 84 and defines an elongate catheter receiving chamber 86 extendingalong a portion of the full longitudinal length of the package 80. Asshown in FIG. 14, a first embodiment of the package 80 may beconstructed from a base sheet of material and cover sheet of materialsealed along side edges 88 a and end edge 88 b to form the catheterreceiving chamber 86 therein. The elongated package 80, best seen inpartial view in FIG. 16, folds at a mid-point 90 so that the first andsecond longitudinal ends 82, 84 meet and are joined into the single endedge 88 b. The first longitudinal end 82 and the second longitudinal end84 are sealed after addition of a lubricating medium in the receivingchamber 86. In a second embodiment the package 80 may be extruded in atube shape and then the first longitudinal end 82 and secondlongitudinal end 84 sealed after addition of a lubricating medium in thereceiving chamber 86, as in shown in FIG. 7B. A third embodiment of thepackage 80 may also be constructed from a single base material foldedupon it to provide a single sealed edge, as in FIG. 7C.

FIG. 14 also shows a score or notch 92 formed at an outer extent of thesealed side edges 88 a at a longitudinal location below the end edge 88b and aligned with the inner chamber 86. An upper portion of thecompacted package may be cut away or torn off using the notch 92 as astarter, as seen in FIG. 15, to expose the inner chamber 86 by removingboth the first and second longitudinal ends 82, 84. FIG. 16 is aperspective view of the package 80 after removal of the first and secondlongitudinal ends 82, 84 and in full longitudinal length from a firstopen end 94 to a second open end 96. Indicator arrows 98 are desirablyprinted on one or both exterior sides of the elongated package 80oriented in one longitudinal direction.

FIG. 17 is a perspective view of the elongated package 80 showing a userinserting an intermittent urinary catheter 100 therein in the directionof the indicator arrows 98. The catheter may be any of the variousembodiments described above, or other types. A leading end of thecatheter is inserted into the first open end 94 and pushed through thechamber 86 having lubricating medium therein.

FIG. 18 shows the intermittent urinary catheter 100 passing completelythrough the elongated package 80, emerging from the second open end 96.A lubricating medium 102 is seen adhered to an outer surface of thecatheter 100 from passing through the catheter-receiving chamber 86.

The package 80 is then used to assist in inserting the catheter 100 intoa urethra. FIG. 19 is a perspective view like FIG. 18 showing the userholding the package 80 with the intermittent urinary catheter 100therein in preparation for use. A portion of the leading end 104 of thecatheter 100 with lubricant 102 thereon extends from the second open end96. The user can easily and cleanly grasp the side of the elongatedpackage 80 to manipulate the leading end 104 into the proper position.Once the leading end 104 is inserted into the urethra, the user canmaintain a grip on the catheter 100 as it is advanced in stages, withthe package 80 sliding back over the catheter so as to continue tolubricate its length. When the process is complete, the package 80 againcan be used to grip and remove the catheter 100 from the urethra.

The stand-alone package 80 described above is easy and convenient to usewith a variety of different catheters. Often, with simple ketchup-stylegel packages used to deposit lubricant on the catheter the gel coatingcan be lumpy and inconsistent. With the catheter 100 passing through thepackage chamber 86, the gel is instead applied evenly and smoothly.Further, the user's fingers remain outside the package 80 at all timesso there is no mess. The package 80 acts as a clean handling sleeve forboth advancing and retracting the catheter. The package 80 is relativelysimple and economical, making it an advantageous way to facilitate theoften messy job of urinary catheter insertion.

FIGS. 20A and 20B are longitudinal sectional and side views of a urinarycatheter 110 contained within an alternative intermittent urinarycatheter package 120 in a folded configuration. Much like the package 20illustrated in FIGS. 1-5, the package 120 has a first longitudinal end123 and a second longitudinal end 124 and defines an elongate catheter110 receiving chamber 128 extending along a portion of the fulllongitudinal length of the package 120. The catheter 110 is carried inthe elongate receiving chamber 128 with a distal end 111 of the catheter110 located proximate the first longitudinal end 123 of the package 120.The package 120 may be constructed from a base sheet of material andcover sheet of material sealed along the edges 127 to form the catheter110 receiving chamber 128 therein. The catheter 110 may be assembledwithin the package 120 in a variety of ways described above with respectto FIGS. 1-5.

FIG. 21 shows the package unfolded with open ends 123, 124. The compactpackaged intermittent urinary catheter 110 is used by patients forself-catheterization. One or more of the compact packaged catheters 110may be easily carried by a patient in a purse, bag or pocket. Prior touse the patient should take all sanitary procedures advised by theirdoctors to decrease the risks of infection from utilizing a catheter110. The patient grasps the first and second longitudinal ends 123 and124 of the compact elastic package 120 and removes the ends 123 and 124together. The ends 123 and 124 may be removed by cutting with a knife orscissors, but preferably the ends 123 and 124 are removed manually alongthe line of weakness 129 or at the point of weakness. As shown in FIG.21, by removing the first longitudinal end 123 and the secondlongitudinal end 124 at the point of weakness or line of weakness 129,the package 120 will be open such that the receiving chamber 128 is nowopen.

A small tab 130 secured to one or both of the first and secondlongitudinal ends 123, 124 ensures that the ends are not completelyremoved. That is, the tab 130 attaches to one or both of the ends 123,124 and spans across line of weakness 129 or score line so as to alsoattach along a portion of one side edge 127 of the package 120. The lineof weakness 129 does not extend through the tab 130, such that when theuser tears off the ends 123, 124, the tab 130 remains connected to theside edge 127. This reduces waste and also facilitates handling of thepackage 120 as the user does not have to dispose of the loose ends 123,124 apart from the rest of the package.

FIG. 22A is a longitudinal sectional view of another intermittenturinary catheter package 140 in a folded configuration, and FIG. 22Bshows the package unfolded with opposite open ends 142, 144. Thecatheter package 140 is generally the same as described above butincludes a biasing member which facilitates expansion from the folded tothe unfolded configuration. More specifically, a catheter 150 containedwithin the inner chamber 152 of the package 140 includes a funnel 154attached to a rear or proximal end. In the folded configuration of FIG.22A, the funnel 154 resides adjacent a central fold line 156.

As seen in FIG. 23, the funnel 154 comprises a molded tubular piece 157which attaches to the catheter 150 and has a biasing member 158extending in a proximal direction. Biasing member 158 resembles a thintongue formed of the same flexible material as the funnel 154 andextends a sufficient distance so that it bends at the fold line 156 byabout 180°. In this way, the biasing member 158 extends from the half ofthe chamber in which the catheter resides into the other half. When theends 142, 144 are opened, the biasing member 158 tends to straightenout, and in the process expands the package 140 from its folded to itsunfolded configuration. Furthermore, by providing a separate funnel 154,the catheter 150 may be formed of one material, such as plastics likepolyethylene, polyvinyl chloride and polyurethane, etc., while theattached funnel 154 may be formed of a more elastic material, such aspolyurethane.

FIG. 24A is a side view of a still further intermittent urinary catheterpackage 160 in a folded configuration, and FIG. 24B shows the package160 unfolded with a catheter 162 extended from one open end. Asexplained above, when unfolded, the catheter 162 may be advanced fromwithin the package 160 and introduced into the urethra until a distalend extends past any constriction causing problems. Urine starts to flowthrough the catheter 162, and the elongated, unfolded package 160 mayfunction as a drain to so as to direct the urine into a toilet or otherreceptacle. FIG. 25 illustrates a convenient manner in which to disposeof the package 160 and catheter 162, once it has been used. That is, adistal end 164 of the catheter 162 may be inserted into the oppositeopen end of the package 160. In this way, the assembly is compact andthe user can grasp the exterior of the package 160 which remains dry fordisposal.

FIG. 26A is a side view of another intermittent urinary catheter package180 in a folded configuration, and FIG. 26B shows the package 180unfolded and a catheter 182 being expelled from one open end thereof.The package 180 may be formed in any of the embodiments describedherein, and as such has a pair of ends 184, 186 which may be torn off ata point of weakness or score line 188.

Instead of filling the inner receiving chamber of the package 180 with alubricant, the catheter 182 has its distal end 184 positioned within agel receptacle 190. The gel receptacle 190 is a hollow chamber filledwith a lubricant that terminates in an introducer tip 192. Theintroducer tip 192 is made of a flexible elastomer which has petals thatthe catheter 182 spreads apart upon passage therethrough. The introducertip 192 helps prevent any bacteria that may be around the urethraopening from contacting the catheter tip, which in turn helps reduceinstances of infection. The user continues to slowly push the catheter182 through the introducer tip 192 and into the urethra until thecatheter reaches the bladder and urine begins to flow. The catheter 182has one or more small eyelets 194 at its distal tip 184 into which theurine flows. The lubricated nature of the catheter 182 eases theinsertion.

Throughout this description, the embodiments and examples shown shouldbe considered as exemplars, rather than limitations on the apparatus andprocedures disclosed or claimed. Although many of the examples presentedherein involve specific combinations of method acts or system elements,it should be understood that those acts and those elements may becombined in other ways to accomplish the same objectives. Acts, elementsand features discussed only in connection with one embodiment are notintended to be excluded from a similar role in other embodiments.

It is claimed:
 1. A compact packaged intermittent urinary catheter,comprising: an elongated intermittent urinary catheter having a roundeddistal end with one or more eyelets opening to a catheter lumen and aproximal end defining an opening to the lumen; and a flexible packagehaving opposite thin sheets of material secured around an outerrectangular periphery and defining a receiving chamber therein, therectangular periphery defining a full longitudinal length from a firstend to a second end, and a lateral fold mid-way between the first andsecond ends, wherein the package is foldable at the fold to convert thepackage into a closed compacted state wherein the first and second endsare secured to each other and the distal end of the catheter is locatedadjacent the first end; wherein the package is configured to convertfrom the closed compacted state to an open extended state bysimultaneously laterally severing the first and second ends from a mainportion of the package to separate the first and second ends and permitthe package to unfold to its full longitudinal length, and whereinlaterally severing the first and second ends also forms first and secondopenings into the receiving chamber at opposite ends of the main portionof the package so that the catheter may be at least partly extractedfrom the receiving chamber.
 2. The compact packaged intermittent urinarycatheter of claim 1, further comprising a guide member having a tetherattached to the first end of the package and the proximal end of thecatheter, wherein removal of the first and second ends of the packageslideably pulls the catheter from the package.
 3. The compact packagedintermittent urinary catheter of claim 1, wherein proximate the firstend of the package the receiving chamber has an inwardly directedshoulder that laterally narrows the receiving chamber, wherein theshoulder is sized, configured, and arranged to prohibit the movement ofa proximal end of catheter from exiting the receiving chamber.
 4. Thecompact packaged intermittent urinary catheter of claim 1, wherein thesheets are made from polyester, polyethylene, polyprolene, aluminum,thermoplastic elastomer (TPE), or combination of those materials.
 5. Thecompact packaged intermittent urinary catheter of claim 1, furthercomprising a weak point proximate the first and second ends selectedfrom the group consisting of a notch and a score line and configured tofacilitate laterally severing the first and second ends.
 6. The compactpackaged intermittent urinary catheter of claim 5, wherein the weakpoint is a lateral score line, and wherein a lateral tab is provided onone lateral edge of the package spanning the score line which maintainsconnection between the first and second ends and the main portion of thepackage.
 7. The compact packaged intermittent urinary catheter of claim1, wherein the package has a biasing means configured and arranged tobias the package to unfold to its full longitudinal length.
 8. Thecompact packaged intermittent urinary catheter of claim 7, wherein thebiasing means is a flexible tongue co-molded with a funnel attached tothe proximal end of the catheter.
 9. The compact packaged intermittenturinary catheter of claim 1, wherein the package receiving chambercontains a lubricating medium, or a gel reservoir is provided in thereceiving chamber through which the catheter passes when being extractedfrom the receiving chamber.
 10. The compact packaged intermittenturinary catheter of claim 1, wherein the urinary catheter lies straightwithin only a portion of the receiving chamber in the closed compactedstate of the package and does not cross the fold.
 11. A compact packagedintermittent urinary catheter, comprising: an elongated intermittenturinary catheter having a rounded distal end with one or more eyeletsopening to a catheter lumen and a proximal end defining an opening tothe lumen, the catheter having a catheter length; and a flexible packageformed of a thin sheet of material defining an elongated receivingchamber therein between a first end to a second end, and a lateral foldmid-way between the first and second ends, wherein the package isconfigured to form a closed compacted state at least half as long as afull longitudinal length of the receiving chamber and at least as longas the catheter length, wherein the first and second ends are secured toeach other and the distal end of the catheter is located adjacent thefirst end; wherein the package is configured to convert from the closedcompacted state to an open extended state by simultaneously laterallysevering the first and second ends from a main portion of the package toseparate the first and second ends and permit the package to expand sothat the receiving chamber extends linearly to its full longitudinallength, and wherein laterally severing the first and second ends alsoforms first and second openings into the receiving chamber at oppositeends of the main portion of the package so that the catheter may be atleast partly extracted from the receiving chamber.
 12. The compactpackaged intermittent urinary catheter of claim 11, further comprising aguide member having a tether attached to the first end of the packageand the proximal end of the catheter, wherein removal of the first andsecond ends of the package slideably pulls the catheter from thepackage.
 13. The compact packaged intermittent urinary catheter of claim11, wherein proximate the first end of the package the receiving chamberhas an inwardly directed shoulder that laterally narrows the receivingchamber, wherein the shoulder is sized, configured, and arranged toprohibit the movement of a proximal end of catheter from exiting thereceiving chamber.
 14. The compact packaged intermittent urinarycatheter of claim 11, wherein the sheets are made from polyester,polyethylene, polyprolene, aluminum, thermoplastic elastomer (TPE), orcombination of those materials.
 15. The compact packaged intermittenturinary catheter of claim 11, further comprising a weak point proximatethe first and second ends selected from the group consisting of a notchand a score line and configured to facilitate laterally severing thefirst and second ends.
 16. The compact packaged intermittent urinarycatheter of claim 15, wherein the weak point is a lateral score line,and wherein a lateral tab is provided on one lateral edge of the packagespanning the score line which maintains connection between the first andsecond ends and the main portion of the package.
 17. The compactpackaged intermittent urinary catheter of claim 11, wherein the packagehas a biasing means configured and arranged to bias the package toexpand so that the receiving chamber extends linearly to its fulllongitudinal length.
 18. The compact packaged intermittent urinarycatheter of claim 17, wherein the biasing means is a flexible tongueco-molded with a funnel attached to the proximal end of the catheter.19. The compact packaged intermittent urinary catheter of claim 11,wherein the compacted state of the package includes a pleatedmid-portion with multiple folds with the first and second longitudinalends being joined together opposite the pleated mid-portion.
 20. Thecompact packaged intermittent urinary catheter of claim 11, wherein thecompacted state of the package includes a coiled mid-portion with thefirst and second longitudinal ends being joined together opposite thecoiled mid-portion.
 21. The compact packaged intermittent urinarycatheter of claim 11, wherein the package receiving chamber contains alubricating medium, or a gel reservoir is provided in the receivingchamber through which the catheter passes when being extracted from thereceiving chamber.